Policy 4.

3 Tuberculosis (active and latent)

in Pregnancy
Title Tuberculosis (active and latent) in Pregnancy
Reference Number WA Tuberculosis Control Program Policy 4.3
Policy Statement This document describes the management of active and latent
tuberculosis (TB) in pregnant women.
Areas Covered Treatment for active and latent TB treatment including drugs
used and adjuvant drugs.
Management of TB in the perinatal period.
Policy sponsor Medical Director, WA TB Control Program
Issued 15 June 2012
Review Date 15 June 2017

Related WA TB Control Program Policies

1.1 Diagnosis of tuberculosis – Laboratory
1.2 Diagnosis of tuberculosis – Clinical
2.1 Medical treatment of tuberculosis (adults)
2.2 Case management of tuberculosis
3.1 Diagnosis of latent tuberculosis infection
3.2 Treatment of latent tuberculosis infection
4.1 Tuberculosis (active and latent) in children
4.2 Management of tuberculosis in prisoners and immigration detainees
4.3 Tuberculosis (active and latent) in pregnant women
4.4 Tuberculosis and HIV
5.1 BCG Vaccination
6.1 Contact tracing for tuberculosis
6.2 Active surveillance for tuberculosis in recent migrants
6.3 Active surveillance for tuberculosis in health care workers
6.4 Active surveillance for tuberculosis prior to anti-TNF alpha treatment
7.1 Notification of tuberculosis and enhanced surveillance data
8.1 Diagnosis and management of Hansen’s disease
9.1 Management of confidential information for the WA Tuberculosis Control Program
9.2 Client record management policy for the WA Tuberculosis Control Program
9.3 Fees and charges associated with tuberculosis and leprosy treatment

Document Control
Version Effective Date Author Comment
1.0 03 February 2012 Initial Document
1.1 15 June 2012 Consultation and review
Policy 4.3 Tuberculosis (active and latent) in
Pregnancy

Table of Contents

TABLE  OF  CONTENTS  ...............................................................................................................................................  2  

1.0   INTRODUCTION  ...............................................................................................................................................  3  
2.0   ACTIVE  TUBERCULOSIS  IN  PREGNANCY  .................................................................................................  3  
2.1     MEDICAL  TREATMENT  .......................................................................................................................................................  4  
2.2   LABOUR  .................................................................................................................................................................................  5  
2.3   BREASTFEEDING  ..................................................................................................................................................................  5  
3.0   PERINATAL  TUBERCULOSIS  ........................................................................................................................  6  
3.1   MEDICAL  MANAGEMENT  ....................................................................................................................................................  6  
4.0   LATENT  TUBERCULOSIS  IN  PREGNANCY  ................................................................................................  7  
4.1     SCREENING  ...........................................................................................................................................................................  7  
4.2     TREATMENT  .........................................................................................................................................................................  7  
5.0   CONCLUSION  ....................................................................................................................................................  8  
6.0   WORKS  CITED  ..................................................................................................................................................  8  
Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

Policy 4.3 Tuberculosis (active and latent) in

Pregnancy
1.0 Introduction

Active tuberculosis (TB) in pregnant women not only has adverse consequences on the
mother and her pregnancy, but can also lead to infection in the neonate during the
antenatal, intrapartum and post partum periods. The neonate can acquire infection through
haematogenous spread via the placenta and umbilical vessels, aspiration or ingestion of
infected amniotic fluid or maternal genital secretions or by air borne transmission from an
infected mother in the post natal period (Adhikari & Jeena, 2009). Most cases of neonatal
TB are due to airborne spread after delivery. Breast milk does not transmit TB.
Transmission of TB from mother to baby is more likely to occur if the mother has miliary or
untreated TB, microscopy detectable acid fast bacilli in sputum specimens or when
maternal disease is diagnosed late (Adhikari & Jeena, 2009).

If left untreated, TB in pregnancy can have a mortality rate of 30-40%, and pregnancy
related complications are seen more frequently (Adhikari & Jeena, 2009). Maternal
complications include a higher frequency of miscarriage, pre-eclampsia and pre-term
labour (Ormerod, 2001). Effects on the foetus include higher rates of perinatal mortality,
prematurity and poor foetal growth. The risk of complications is increased with late
diagnosis.

2.0 Active Tuberculosis in Pregnancy

The clinical presentation of tuberculosis (TB) in pregnancy is similar to that in non-

pregnant women but diagnosis may be delayed by non-specific symptoms of malaise and
fatigue, which also occurs in pregnancy (Ormerod, 2001). Any delay in diagnosis and
treatment increases the risk of obstetric and perinatal complications. Diagnosis may also
be late when chest x-ray is postponed or delayed due to concerns of radiation exposure to
the developing foetus. Extrapulmonary TB occurs in 5-10% of TB diagnosed in pregnant
woman, which is comparable with non-pregnant women (Adhikari & Jeena 2009; Ormerod,
2001).

The clinical assessment and investigations used to investigate suspected tuberculosis in

pregnant women are the same as the general population (see the WA TB Control Program
polices 1.1 and 1.2 Diagnosis of Tuberculosis). Investigations should include the
examination and culture of sputum specimens for M.tuberculosis and other specimens
collected as appropriate for those body sites involved e.g. lymph node aspirate, pleural
fluid, and endometrial samples. The placenta delivered from a mother with TB, especially if
disseminated or miliary, should be examined microbiologically and histologically for
evidence of TB. A chest x-ray is required if recent infection is suspected to look for
asymptomatic but radiological active pulmonary TB and can be performed with abdominal
lead shielding to protect the foetus.

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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

2.1 Medical Treatment

If TB is diagnosed in a pregnant woman, treatment must be started as soon as possible to

avoid the serious effects of tuberculosis upon the women, upon the foetus and the
neonate, and to limit the infectiousness of the woman.

First-line treatment of TB in pregnant women is no different to non-pregnant women. The

standard 6-month regimen of an initial 2 months isoniazid, rifampicin, ethambutol and
pyrazinamide followed by 4 months of isoniazid and rifampicin (2HREZ4HR) is used with
daily dosing rather than intermittent therapy preferred. For details of drug doses and
circumstances in which this regimen may be altered see the WA TB Control Program
policy 2.1 Medical Treatment of Tuberculosis (adults) sections 5.0 and 6.0.

Pyrazinamide

In some jurisdictions (American Thoracic Society, CDC and Infectious Diseases Society of
America, 2003) pyrazinamide is not recommended for routine treatment of TB in
pregnancy, because of a lack of published evidence regarding its safety. Conversely the
WHO (World Health Organisation, 2009) and the International Union Against TB & Lung
Disease (Caminero, 2003) do not recommend against its use, and it has an Australian
Category B2 classification for risk of drug use in pregnancy. Given the lack of reported
adverse outcomes in pregnancy and the importance of PZA in short course chemotherapy
of TB, pyrazinamide is recommended for routine use in pregnant patients in WA
(Therapuetic Guidelines Limited, 2010). This discrepancy in recommendation should be
discussed with the patient at the beginning of therapy and in gaining the patient's informed
consent to use an unlicensed product.

If pyrazinamide is not included in treatment, a nine month regimen should be used

consisting of an initial 2 months of isoniazid, rifampicin and ethambutol therapy followed by
a 7 month continuation phase of isoniazid and rifampicin (2HRE7HR) (American Thoracic
Society, CDC and Infectious Diseases Society of America, 2003).

Rifampicin

Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and

in mothers after the use of rifampicin during late pregnancy. This is a rare adverse
outcome. The physician treating the TB should ensure the midwife and/or obstetrician
managing the delivery is aware of this possibility. MIMS©1 recommends the mother and
newborn receive Vitamin K (MIMS, 2012), but there is no evidence to support this, and in
WA it is not routine management. This is not a reason to stop or withhold treatment with
rifampicin.

1
MIMS© is an Australian comprehensive medicines reference.
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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

The following drugs are contraindicated in pregnancy (Ormerod, 2001):

• Aminoglycosides, including Kanamycin and amikacin
• Streptomycin (ototoxic to the foetus),
• Ethionamide (CNS defects) and
• Capreomycin (use with caution if absolutely required)

Liver function should be monitored frequently due to the increased risk of drug-associated
liver toxicity during pregnancy and the early peripartum period.

Pyridoxine

Pyridoxine supplementation is recommended for all pregnant or breastfeeding women

taking isoniazid (World Health Organisation, 2009). Isoniazid-induced peripheral
neuropathy usually presents as numbness or a tingling or burning sensation of the hands
or feet and occurs more commonly in pregnant women. The dose of pyridoxine should be
25mg / day (Centers for Disease Control and Prevention, 2008).

Babies being breastfed by mothers who are taking isoniazid should be given pyridoxine
5 mg daily on the days that the mother receives her isoniazid dose (Therapuetic
Guidelines Limited, 2010).

2.2 Labour

Those women with fully susceptible pulmonary TB on first-line treatment should not be
infectious after two weeks of commencement of anti-TB therapy and should be allowed to
deliver as normal. If delivery occurs prior to two weeks of anti-TB therapy and the mother
has sputum smear positive TB, then delivery should be conducted in a negative pressure
room and appropriate infection control measure taken. The neonate will require preventive
treatment and contact tracing procedures followed as usual.

2.3 Breastfeeding

Breast-feeding should not be discouraged if a woman is on treatment for active TB. The
concentration of anti TB medication found in breast milk is not associated with toxicity to
the neonate and all breastfeeding mothers who are receiving isoniazid medication should
continue to take pyridoxine supplement (World Health Organisation, 2009, Centers for
Disease Control and Prevention, 2008). The concentration of anti-TB medication found in
breast milk is too small to be an effective treatment for TB or latent TB in the nursed baby.
The neonate born to mothers with active TB should receive their own treatment for either
active TB or preventive therapy, with pyridoxine supplement as discussed below.

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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

3.0 Perinatal tuberculosis

Transmission of TB from a mother to the foetus or neonate is most likely to occur when the
mother has untreated or disseminated TB, sputum smear positive TB or when TB is
diagnosed late in the pregnancy. Perinatal tuberculosis encompasses tuberculosis
acquired by the baby while i) in-utero, ii) intrapartum and iii) in the postnatal period.

Tuberculosis acquired by the foetus in-utero from haematogenous spread via the umbilical
cord, or in-utero aspiration or ingestion of infected amniotic fluid is rare. It should be
considered if the mother has been diagnosed with genital tract TB, especially if late in the
pregnancy, and the neonate develops signs of sepsis.

Tuberculosis can be spread to the neonate during delivery by aspiration or ingestion of

infected amniotic fluid or cervicovaginal secretions. Tuberculosis infection acquired after
delivery occurs from airborne infection from the mother, an adult family carer or another
infectious adult with whom the infant has had contact (including health care workers).

3.1 Medical management

A paediatric specialist should always be involved in the management of children at risk of

or suspected to have neonatal tuberculosis. The diagnosis of perinatal tuberculosis is
difficult and frequently delayed. If the neonate exhibits any signs or symptoms of TB
infection then a thorough assessment and investigation should be undertaken for bacterial
confirmation of M.tuberculosis infection. Symptoms and signs that should raise suspicion
of TB in a neonate born to a mother diagnosed with active TB would be fever, respiratory
distress, hepatosplenomegaly, jaundice, lymphadenopathy or an abnormal chest x-ray.
The clinical features can be subtle and difficult to differentiate from other congenital /
neonatal infections.

Standard anti-TB therapy should be commenced after appropriate specimens have been
collected. Paediatric drug regimens and doses are discussed in more detail in the WA TB
Control Program policy 4.1 Tuberculosis (active and latent) in children.

After active TB has been excluded in the baby, the neonate should receive preventive
therapy as per normal contact tracing procedures. Infants who have been exposed to a
mother with fully susceptible TB should be offered preventive therapy with either 6 months
isoniazid (10mg/kg) and pyridoxine supplement (5-10 mg daily), or 3 months combination
therapy of isoniazid (10mg/kg) and rifampicin (15mg/kg) with pyridoxine supplement
(World Health Organisation, 2010). During treatment dosages may require adjustment to
reconcile the effect of age, weight gain and possible toxicity in young infants. The decision
to adjust dosages should be taken by a clinician experienced in managing paediatric
tuberculosis.

If during the period of preventive therapy the infants develops clinical symptoms or signs
or radiological appearances suggestive of active TB then appropriate investigations should
be done to exclude active TB and a complete course of anti-TB treatment considered.
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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

Contact tracing among the rest of the family and other close contacts of the infected
mother must also be performed. This is to ensure that others are not infected with TB.

4.0 Latent Tuberculosis in Pregnancy

4.1 Screening

Routine screening for latent TB infection (LTBI) is pregnancy is not necessary, however, it
may be warranted in selected groups:
• Close contacts of infectious TB.
• Recent arrivals from countries with TB incidence rate of >50 per 100,000
population. Individual country incidence rates for TB can be found through the
World Health Organisation tuberculosis country profile website
http://www.who.int/tb/country/data/profiles/en/index.html.
• HIV infected patients (and other profoundly immunocompromised patients).

The tuberculin skin test (TST) is the test of choice and tuberculin reactivity is not affected
by pregnancy. It is considered both a valid and safe test to use in pregnancy. The
Interferon Gamma Release Immunoassays (IGRAs), of which QuantiFERON-TB Gold In-
Tube (QIFN) test is used in Western Australia, are also safe to use in pregnancy for
screening, but this test has not been validated for pregnant women.

It is recommended that asymptomatic pregnant women with a positive TST or QIFN and
with risk of progressing to active disease e.g. recent contact of TB, HIV co-infection,
should have a chest x-ray after 12 weeks gestation to exclude asymptomatic but
radiological active pulmonary TB. However, if the patient is not agreeable to this, then it
can be deferred until after pregnancy.

4.2 Treatment

The preferred regimen for preventive therapy in pregnant women is isoniazid daily for 6
months with pyridoxine 25mg/day supplementation. Isoniazid is a category A drug and is
safe to use in pregnancy. The usual dose is 300mg per day. The decision to treat should
be made in conjunction with the patient’s preference. Treatment should be encouraged
during pregnancy when there is a high risk of progression to active disease. That is if the
woman:
- Is a recent close contact with active TB,
- Has HIV infection or is severely immunocompromised, or
- Has another medical condition, which increases the risk of reactivation of LTBI.

If preventive treatment is to be deferred until after delivery then the pregnant woman
should be closely monitored for signs of active disease.

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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

5.0 Conclusion

M.tuberculosis infection in a pregnant woman can not only cause disease in the mother,
but also expose the foetus and neonate to an increased risk of TB. A high index of
suspicion for TB should be present when assessing a woman from a high TB prevalent
country or who is a recent contact of TB especially if she exhibits any symptoms or signs
of active TB disease. Any delay is diagnosis or investigation for TB should be avoided.
First-line treatment for TB is the same in pregnant women as for non-pregnant women and
pyridoxine supplement should always be given. Post delivery the neonate must be
assessed for active TB disease and appropriate treatment commenced in consultation with
a paediatrician experienced in TB management. If active disease in the neonate is absent
then preventive therapy should be offered. Breast-feeding should still be encouraged in TB
affected mothers.

6.0 Works Cited

Adhikari, M., & Jeena, P. (2009). Tuberculosis in pregnancy and in the neonate. In H.
Schaaf, & A. zumla, Tuberculosis: a comprehensive clinical referecne (pp. 572-580).
Europe: Saunders Elsevier.

American Thoracic Society, CDC and Infectious Diseases Society of America. (2003).
Treatment of Tuberculosis. MMRW Morb Mortal Wkly Rep , 53 (RR11), 1-77.

Caminero, J. (2003). A Tuberculosis Guide for Specialist Physicians. Paris: International

Union against Tuberculosis and Lung Disease.

Centers for Disease Control and Prevention. (2008). Tuberculosis and pregnancy.
Retrieved September 28, 2011 from Centers for Disease Control and Prevention:
http://cdc.gov/tb/publications/factsheets/specpop/pregnancy.htm

MIMS online. (2012). Rifampicin: Full product information. Retrieved June 11, 2012 from
MIMS online: http://www-mimsonline-com-au:nmahslibresources.health.wa.gov.au
[Department of Health, WA intranet]

Ormerod, P. (2001). Tuberculosis in pregnancy and the puerperium. Thorax , 56 (6), 494-
499.

Therapuetic Guidelines Limited. (2010, February). Tuberculosis in pregnancy and

breastfeeding. eTG complete [Internet] . Melbourne, Austalia.

World Health Organisation. (2010). Rapid advice: treatment of tuberculosis in children.

Retrieved November 02, 2011 from World Health Organisation:
http://whqlibdoc.who.int/publications/2010/9789241500449_eng.pdf

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Public Health and Ambulatory Care, North Metropolitan Health Service Policy 4.3 WA TB Control Program

World Health Organisation. (2009). Treatment of tuberculosis: guidelines. Retrieved

November 02, 2011 from World Health Organisation:
http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf

World Health Organisation. (2011, October 26). Tuberculosis Country Profiles. Retrieved
October 26, 2011 from http://www.who.int/tb/country/data/profiles/en/index.html

Endorsing Authority
Policy or Procedure Sponsor Medical Director, WA TB Control Program
Last Reviewed 15 June 2012
Next Review date 15 June 2017
References (Standards)
Th
EQuiP EQuiP (5 edition) criteria 1.1.1, 1.1.2, 1.2, 1.3.1, 1.4.1, 1.5.1
Legislation WA Health Act (1911)
Standards
Related Documents WA TB Control Program Policy Documents

**Feedback or comments related to this policy should be addressed to the Medical

Director, WA TB Control Program Justin.Waring@health.wa.gov.au